Medical Writer

Description

The Medical Writer is responsible for planning, authoring, editing, and finalizing high-quality clinical and regulatory documents in support of Viking Therapeutics’ clinical development programs. Reporting to the Vice President, Clinical Development, this role partners closely with internal Clinical Development, Biostatistics, Clinical Operations, Regulatory Affairs, and Pharmacovigilance/Drug Safety teams, as well as with external contract research organizations (CROs) and specialty vendors, to produce phase-appropriate documents from early-stage development through late-stage clinical and pre-approval activities.

The Medical Writer will develop clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), safety and periodic reports, and the clinical sections of regulatory submissions, as well as scientific abstracts, manuscripts, and presentations, across Viking’s portfolio, including the company’s lead GLP-1/GIP dual agonist programs (VK2735) and additional metabolic and endocrine disorder pipeline assets. The level of the role will be commensurate with the candidate’s experience and qualifications.

The main responsibilities of this role include:

• Author, review, edit, and finalize clinical and regulatory documents – including clinical study protocols and amendments, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), and the clinical sections of regulatory submissions (INDs, CTAs, NDAs) – in accordance with ICH-GCP, applicable regulatory guidance, and Viking standard operating procedures.
• Review safety and periodic reports (e.g., Development Safety Update Reports) and clinical narratives, and support timely, accurate responses to health authority questions in collaboration with Regulatory Affairs and Pharmacovigilance.
• Develop briefing documents and regulatory meeting materials (e.g., pre-IND, End-of-Phase 2, and advisory committee or scientific advice packages).
• Establish and manage document timelines, coordinate cross-functional reviews, and lead comment resolution and document finalization to meet submission deadlines.
• Ensure scientific accuracy, consistency, and adherence to style guides, templates, and document standards across the clinical document set.
• Manage medical writing deliverables outsourced to external CROs, contract medical writers, and vendors; provide direction, review, and quality oversight of outsourced documents.
• Maintain compliance with ICH-GCP, applicable FDA and EMA regulations, and data integrity (ALCOA+) and good documentation practices; support version control and archival within the electronic document management system.
• Contribute to the development and continuous improvement of medical writing templates, style guides, and standard processes.
• Other duties as assigned.

• Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline with 4+ years of relevant regulatory/clinical medical writing experience in the pharmaceutical or biotechnology industry; or an advanced degree (M.S., Pharm.D., or Ph.D.) with correspondingly relevant experience.
• Demonstrated experience authoring clinical-regulatory documents (e.g., protocols, CSRs, IBs, or clinical submission sections) within a GCP environment.
• Title and level will be commensurate with the candidate’s experience and qualifications.

• Strong working knowledge of ICH-GCP, ICH E3 (clinical study report structure), the CTD/eCTD framework, and regulatory requirements for clinical documentation.
• Excellent scientific and technical writing skills, with the ability to translate complex…